UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 13, 2025 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) | Delaware | 001-39070 | 32-0463781 | | --- | --- | --- | | (State or other jurisdiction | (Commission | (I.R.S. Employer | | of incorporation) | File Number) | Identification No.) | 1000 Skokie B ...

Financial Position - As of September 30, 2025, the company's cash, cash equivalents, and investments totaled $143.7 million, expected to last through at least December 31, 2027[144]. - The company reported a net cash inflow of $81.86 million for the nine months ended September 30, 2025, compared to a net cash outflow of $1.25 million for the same period in 2024, marking an increase of $83.11 million[187]. - Cumulative negative cash flows from operations resulted in an accumulated deficit of approximately $84.3 million as of September 30, 2025[184]. - Cash used in investing activities increased by $1,264,561 during the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to net investments in U.S. Treasury securities[189]. - Cash flow provided by financing activities increased by $88,803,654 during the nine months ended September 30, 2025, mainly due to net proceeds of approximately $91.9 million from the September 2025 capital raise and share repurchase[190]. Share Transactions - The company sold 1,181,540 shares at $16.25 per share on October 30, 2024, yielding net proceeds of approximately $17.8 million[146]. - A public offering on December 23, 2024, resulted in the sale of 798,655 shares at $23.79 per share, generating net proceeds of approximately $37.4 million[147]. - On September 23, 2025, the company sold 1,034,433 shares at $67.67 per share, with net proceeds of approximately $91.9 million after a $35 million share repurchase[148]. Research and Development - ALXN1840 for Wilson disease has shown three-times greater copper mobilization compared to standard-of-care in a Phase 3 trial, with a Least Square Mean Difference of 2.18 µmol/L (p< 0.0001)[152]. - The company plans to submit a New Drug Application (NDA) for ALXN1840 to the FDA in early 2026[159]. - MNPR-101-Zr has received regulatory clearance in Australia for a Phase 1 imaging trial, with positive early clinical data reported[160]. - The FDA cleared the IND application for MNPR-101-Lu on September 26, 2025, for a Phase 1 trial targeting uPAR-expressing tumors[163]. - The company is actively exploring opportunities to expand its radiopharmaceutical pipeline through internal development efforts[164]. - The company has two active human clinical trials for its MNPR-101 radiopharmaceutical program, focusing on advanced cancers[170]. - Research and development (R&D) expenses for Q3 2025 were $2.59 million, a 163% increase from $0.98 million in Q3 2024, primarily due to increased manufacturing activities related to ALXN1840[177]. - R&D expenses for the nine months ended September 30, 2025, were $5.96 million, a 93% increase from $3.08 million in the same period in 2024[178]. General and Administrative Expenses - General and administrative (G&A) expenses for Q3 2025 were $1.50 million, up 154% from $0.59 million in Q3 2024, mainly due to increased Board compensation and personnel expenses[179]. - G&A expenses for the nine months ended September 30, 2025, were $4.59 million, up 129% from $2.01 million in the same period in 2024[180]. Financial Performance - The net loss for Q3 2025 was $3.44 million, compared to a net loss of $1.30 million in Q3 2024, reflecting a variance of $2.13 million[176]. - Interest income for Q3 2025 increased by $556,129 compared to Q3 2024, attributed to higher bank balances and interest earned on U.S. Treasury securities[181]. - The company has not generated any revenue from product sales to date and does not expect to do so until regulatory approval and commercialization of drug candidates are achieved[191]. - Anticipated expenses are expected to increase significantly as the company continues research, development, and clinical trials for current and future drug candidates[192]. Obligations and Agreements - The company has obligations to pay Alexion milestone payments of up to $94.0 million for regulatory approval and sales-related milestones, along with tiered royalties based on net sales ranging from 10% to 20%[200]. - A long-term, non-exclusive master supply agreement with NorthStar for the therapeutic radioisotope actinium-225 was established, clarifying economic terms and jointly-developed intellectual property rights[202]. - The company has a non-exclusive license with XOMA Ltd. for humanization technology, with potential milestone payments totaling up to $14.925 million, but no payments have been made as of October 31, 2025[203]. Future Financing - The company expects to finance future cash needs primarily through equity offerings, debt financings, strategic collaborations, and grant funding, which may dilute current stockholders' ownership[197]. Lease and Legal Proceedings - The company entered into a 36-month lease for executive headquarters at a monthly rate of $3,580, along with additional leases for laboratory space[205]. - The company has not been involved in any adverse material legal proceedings to date[206]. Management Experience - The management team has extensive experience, having achieved four drug approvals and three diagnostic device approvals in the U.S. and EU[165].

Core Viewpoint - Monopar Therapeutics Inc. reported its third quarter 2025 financial results, highlighting advancements in its drug candidates and recent financing activities, indicating a strong position for future growth and regulatory submissions [1]. Recent Developments - ALXN1840 for Wilson Disease: New data presented at the 150th American Neurological Association Annual Meeting demonstrated long-term neurological efficacy and safety of ALXN1840, emphasizing its potential to positively impact both neurological and hepatic manifestations of Wilson disease [2][3]. - MNPR-101 for Radiopharmaceutical Use: The FDA cleared the IND application for MNPR-101-Lu, which aims to treat advanced or metastatic solid tumors, utilizing proprietary linker technology to enhance therapeutic efficacy [5]. Recent Financing Capital Raise and Share Repurchase - On September 23, 2025, Monopar priced a public offering of 1,034,433 shares at $67.67 per share, raising approximately $126.9 million in net proceeds [6]. - Following the offering, the company repurchased 550,229 shares from Tactic Pharma for $35 million, resulting in net proceeds of approximately $91.9 million after the share repurchase [7]. Financial Results for the Third Quarter Ended September 30, 2025 - Cash, cash equivalents, and investments totaled $143.7 million, sufficient to support operations through at least December 31, 2027, while advancing multiple clinical trials and R&D projects [9]. - The net loss for Q3 2025 was $3.4 million, or $0.48 per share, compared to a net loss of $1.3 million, or $0.37 per share, in Q3 2024 [10]. - R&D expenses increased to $2.59 million, primarily due to higher manufacturing activities and personnel costs [11]. - G&A expenses rose to $1.50 million, driven by increased board compensation and personnel expenses [12]. - Interest income increased by $556,129, attributed to higher bank balances and interest earned on U.S. Treasury securities [13]. Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, with key programs including ALXN1840 for Wilson disease and various radiopharmaceutical candidates [14].

Core Insights - Monopar Therapeutics Inc. is presenting new data from the Phase 2 ALXN1840-WD-204 copper balance study at the AASLD conference, highlighting the company's focus on innovative treatments for unmet medical needs [1][2] Study Findings - The oral presentation by Professor Aftab Ala indicates that treatment with ALXN1840 (tiomolybdate choline) resulted in a rapid and sustained improvement in daily copper balance in Wilson disease patients, primarily through increased fecal copper excretion [2] - The mean daily copper balance among patients treated with ALXN1840 (n=8) showed significant improvement compared to pre-treatment baseline, with positive results observed during both the initial 15 mg once-daily dosing period (days 1-28) and the entire treatment duration (days 1-39) [3] Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company with a focus on late-stage ALXN1840 for Wilson disease and various radiopharmaceutical programs, including MNPR-101-Zr for imaging advanced cancers and MNPR-101-Lu and MNPR-101-Ac225 for treating advanced cancers [5]

Core Viewpoint - Monopar Therapeutics Inc. (MNPR) has seen a 21.2% increase in share price over the past four weeks, closing at $77.15, with a potential upside of 42.5% based on Wall Street analysts' mean price target of $109.91 [1][4]. Price Targets - The average of 11 short-term price targets ranges from a low of $85.00 to a high of $142.00, with a standard deviation of $17, indicating variability among analysts [2]. - The lowest estimate suggests a 10.2% increase from the current price, while the highest estimate indicates an 84.1% upside [2]. Analyst Consensus and Earnings Estimates - Analysts are increasingly optimistic about MNPR's earnings prospects, as evidenced by a positive trend in earnings estimate revisions, which historically correlate with stock price movements [4][11]. - The Zacks Consensus Estimate for the current year has risen by 5.9% over the past month, with five estimates increasing and no negative revisions [12]. Zacks Rank - MNPR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting a strong potential upside [13]. Caution on Price Targets - While price targets are a common metric for investors, they should be approached with skepticism as they can often mislead, and analysts may set overly optimistic targets due to business incentives [3][7][10].

Core Insights - Monopar Therapeutics Inc. has been identified as a promising investment opportunity, with Raymond James raising its price target from $80 to $142 while maintaining a Strong Buy rating [1][3] Financial Performance - In Q2 2025, Monopar reported a net loss of $2.5 million ($0.35 per share), an increase from a net loss of $1.7 million ($0.49 per share) in Q2 2024 [2] - The company has cash, cash equivalents, and investments totaling $53.3 million, which is expected to support operations through December 31, 2026 [2] Development Pipeline - The increased price target reflects confidence in the company's ability to execute its anticipated timeline, including filing an NDA for ALXN1840, completing its Phase 1 imaging/dosimetry trial for MNPR-101-Zr, continuing its Phase 1a therapeutic trial for MNPR-101-Lu, and advancing the preclinical MNPR-101-Ac program into the clinic [3]

Core Insights - Monopar Therapeutics Inc. announced that its abstract on the Phase 2 ALXN1840-WD-204 copper balance study has been selected for an oral presentation at the AASLD – The Liver Meeting 2025, scheduled for November 7-11, 2025 in Washington, D.C. [1] Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, with late-stage ALXN1840 for Wilson disease and various radiopharmaceutical programs [3] - The company is also working on Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for treating advanced cancers [3] Presentation Details - The abstract for the oral presentation is available on the conference website, with materials to be accessible on Monopar's website on November 9, 2025 [2] - The presentation will take place on November 9, 2025, from 9:00-9:15 am EST, featuring the presenting author Aftab Ala, MBBS, M.D., FRCP, Ph.D. [5]

Market Outlook - Ryan Detrick, chief market strategist at Carson Group, anticipates a strong end-of-year rally despite historically weak periods in late September and early October [1] - The market has experienced five consecutive months of gains, which historically leads to an average decline in October, suggesting a potential break for investors [1] - Q4 typically shows a median return of nearly 6% when the market has been up for five months prior, indicating bullish sentiment [1] Investment Strategy - Detrick expressed a desire for a mild correction of 4-6%, viewing it as a healthy market adjustment [2] - Current market indicators include low put-to-call ratios and a significant inflow of $58 billion into US equity funds, the highest this year [2] - Anticipated volatility around Jewish holidays and early October may present buying opportunities, driven by strong earnings and consumer performance [2] Company Highlights Monopar Therapeutics Inc. (NASDAQ:MNPR) - Achieved a 3-month performance of 100.82% as of October 10, with an average upside potential of 20.70% [7][8] - Raymond James raised the price target from $80 to $142, maintaining a Strong Buy rating, indicating confidence in the company's future performance [8] - Reported a net loss of $2.5 million for Q2 2025, an increase from a net loss of $1.7 million in Q2 2024, with cash reserves of $53.3 million to support operations through December 2026 [9] Mesoblast Limited (NASDAQ:MESO) - Recorded a 3-month performance of 64.01% as of October 10, with an average upside potential of 56.16% [11] - The company received a permanent J-Code for its product Ryoncil, enhancing billing and reimbursement pathways, which is a significant commercial milestone [12] - Ryoncil is the first FDA-approved mesenchymal stromal cell product for pediatric patients with steroid-refractory acute graft-versus-host disease, expanding its market potential [13][14]

Group 1 - Top Wall Street analysts have revised their outlook on several key stocks, indicating a shift in market sentiment [1] - The article suggests that investors consider buying MNPR stock based on analysts' recommendations [1]

Group 1 - Monopar Therapeutics Inc. has experienced a significant surge in its stock price over the past year, moving from a market cap under $9 million to a more favorable position following its acquisition of the Wilson disease candidate ALXN-1840 [1] - The company had cash reserves of $7.1 million prior to the surge, indicating a previously precarious financial situation [1] Group 2 - The Busted IPO Forum, led by Bret Jensen, focuses on small-cap stocks that have been public for 18 months to 6 years and are trading significantly below their offering price [1]